MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.5 HEALIXADVPEEK3SUTANC PCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	223135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair the 4.5 helaix advance peek 3 suture anchor w/  permacord broke during insertion.The physician removed all the fragments generated.5 minutes delay to the procedure were reported.No patient consequences.The procedure was successfully completed with another anchor.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the sales rep believed that the physician was just off access but wanted him to document that the device broke.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.The sales rep informed us that the physician was just off axis, therefore is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number (6l31649), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history review: manufacturing record evaluation was performed for the finished device lot number (6l31649), and no non-conformances were identified.

• Brand Name: 4.5 HEALIXADVPEEK3SUTANC PCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9667919
• Report Number: 1221934-2020-00476
• Device Sequence Number: 379846
• Product Code: MAI
• UDI-Device Identifier: 10886705024759
• UDI-Public: 10886705024759
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 223135
• Device Catalogue Number: 223135
• Device Lot Number: 6L31649
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 03/23/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/10/2020; 03/24/2020
• Patient Sequence Number: 1